Sterile medicated strips



Jan; 29', 1963 A. w. BECHTOLD ,0

STERILE MEDICATED STRIPS Filed June 2, 1960 IMPREGNATED, NOTCHED ENDVARNISHED END IN V EN TOR.

ARTHUR W. BECHTOLD 3am Ma ATTORN S 3,075,527 STERILE MEDIQATED STRIPSArthur W. Bechtold, Isiip, N.Y., assignor, by mesne assignments, toChernway Corporation, Wayne, N.J., a corporation of Delaware Filed dune2, 1969, Ser. No. 33,510 7 Claims. (Cl. 12826t This invention relates tothe treatment of the eyes and particularly to a new carrier ofmedicament, to a method of making it, and to a novel method ofintroducing a medicament to the eye. The invention is particularlyuseful when it is desired to introduce to the eye a very small quantityof medicament, for instance less than one drop.

One object of this invention is to prepare medicaments in a sterile,solid form adapted to immediate use.

Another object is to provide medicated applicators which require noinstruments for application.

Another object is to avoid the use of liquid in the treatment of theeye.

Another object is to prepare a novel applicator for ophthalmicmedicaments soluble in tears.

Another object is to apply dry medicaments to the eye in the treatmentof ophthalmic diseases.

The standard method of applying medicament to the eye is to use adropper. This requires a bottle for the medicament, a stopper which ishandled, a dropper, a container for the dropper and sometimes asterilizer or a sterilizing solution for the sterilization of thedropper. The use of the dropper is not altogether satisfactory when verysmall quantities or" medicament are to be applied, for instance lessmedicament than would be included in one or two drops. In some cases thecarrier liquid is irritating and it is desirable to apply the medicamentin a dry state. After a bottle is opened, the contents are sometimesregarded as not sterile, resulting in the loss of expensive medicament.

The objects of the invention are accomplished, generally speaking, by anophthalmic applicator which in its preferred form is an elongated, flatstrip of soft fabric, a part of which is impregnated with a drymedicament miscible with tears. A preferred method of making theapplicator is to apply a suitable quantity of a medicament solution ofselected concentration to a soft textured, bibulous filter paper, dry itin warm air, seal it in an envelope, and sterilize it. In preferredcases the absorbent strip is varnished at one end and the medicament isapplied only to the other. The varnish is dried before the medicament isapplied. The medicament is applied as a solution of selected strength tothe unvarnished part of the strip and the solution is dried leaving thepaper impregnated with dry medicament. The medicament used is preferablyof such nature that it is soluble in tears and in such common solventsas water or alcohol. After the strip has been dried it is cut by sterilemeans into small strips, each of which includes a quantity certain ofmedicament, for instance the dried content of one, two or more drops.These small strips, for instance 2" long x wide may have rounded andnoticed ends and may be packaged in small polyethylene envelopes andsterilized. Sterilization is preferably done by the ethylene oxidemethod, as described in my copending application Serial No. 679,196 nowPatent No. 3,032,182.

Example I.The paper to be used in preparing these medications is ahighly absorbent, soft textured, bibulous filter paper which isvarnished on both sides almost to the tip to prevent the distribution ofthe introduced solution throughout its length by capillary action. Thevarnish may be of any type but especially of neutral, quick dryingresinous type, such as Bakelite. This paper then is die-cut to a narrowstrip which is notched on one end.

I 3,075,527 Patented Jan. 29, 1963 The absorbent end is exposed to onedrop of medication for instance containing .125 mg. of tetracainehydrochloride, introduced by either a mechanized syringe capable ofdispensing one drop at a time, pipetting manually, or dipping in asolution. The strips are dried in warm air-current and packagedindividually in a transparent bag such as described in my copending casewhich would admit and maintain sterility. The ready strip is sterilizedin ethylene oxide. Materials other than paper, that have absorbingqualities, may be used instead of paper strips i.e. gauze, and fabricsbut they should be lintless and soft.

In use a sterile package containing a medicated strip is opened, themedicated strip is taken by its varnished end, and the soft,medicament-impregnated end of the strip is tucked inside the eyelid, forinstance inside the lower lid where the medicament, being soluble intears, is absorbed and distributed by the tears of the eye to the placeswhich require treatment.

Typical of the medicaments which can be applied in this Way arehomatropine HBr, atropine sulfate, pilocarpine HCl, eserine salicylate,carbamylcholine chloride, and tetracaine HCl.

In place of the filter paper there can be used any soft absorbentmaterial, that is to say, any material which is acceptable to the eyewithout too much irritation, which will absorb an adequate quantity ofmedicament solution such as soft cotton or linen fabrics, and syntheticssuch as woven strands of inert plastic threads. The shape of theapplicator can be as desired being rounded, notched, or any otherconvenient shape at the end which is to be inserted in the eye. It isunnecessary to varnish the strip although varnish, or a high size, orlacquering has the advantage of limiting the penetration of themedicament solution into the paper and of preventing moisture on thehands of the physician from travelling through the fabric to themedicated end. impregnation by means of water solution of the drug issatisfactory, but alcoholic solutions may also be used for impregnationand have the advantage of drying faster.

In some instances it is desirable to include in the solution a smallamount of visible indicator, examples of which are rose bengal andfiuorescein sodium, so that the physicians may be able to estimate howmuch of the medicine will be absorbed by tears. By observing the colorof the tears as they dissolve the medicine a reasonable estimation canbe made of the quantity of medicine which has been taken. In what may beconsidered standard practice, it is satisfactory to include up to 3 mg.of such dyes in the impregnated end of the strip.

In impregnating as in Example I one may assume that 20 drops equal 1 cc.and make up solutions that contain in one drop the following quantitiesof medicament.

Amt. Percent Present,

One Drop 525 include in a solution that quantity of the desiredmedicament which will deposit the quantity of medicament desired in theapplicator.

Example II.A paper strip 1 /2 wide, 1 long and made of soft filter paperwas varnished on both sides except for a strip Wide along one long edge.A solution of atropine sulfate was made up to contain 0.125 mg. ofmedicament per drop. Drops of the solution were placed 4 apart on theexposed edge of the filter paper and allowed to dry in warm air. Thestrip was cut apart between the drops producing 48 small strips each ofwhich contained about 0.125 mg. of the medicament. Each of these smallstrips was placed in a small envelope of polyethylene which was sealedthereafter. The sealed strips were placed in the autoclave which wasclosed and filled with ethylene oxide in a non-explosive concentration.The ethylene oxide penetrated the polyethylene envelope and sterilizedthe contents. In using the strip the doctor opened the envelope at thevarnished end of the strip, removed the strip from the envelope, andimmersed it in the tears of the eye gathered in the lower lid. Themedicament, being soluble in tears was dissolved out of the strip andcarried throughout the eye.

Air drying was used in drying the impregnated paper in this example, butin general drying will be carried out at elevated temperatures underreasonably sterile conditions. Absolute sterilization of impregnationand drying is not necessary where the strips are to be sterilized afterpackaging. In some cases, where it is desirable to have greaterconcentrations of medicament than can readily be applied in a singledrop, repeated impregnations and dryings may be resorted to. Where agreater concentration of medicament is desired in the tears than can beobtained from a single strip, the physician can apply more than onestrip.

In each instance the envelope containing the applicator strip will belabeled with the name and quantity oi medicament carried.

The advantages of the invention are in the accomplishving of theobjectives of the invention. There are other advantages, for instanceover the application of medicaments by the dropper. The quantity ofliquid which the eye can retain is small and the addition of more thanthat limited quantity achieves no purpose, but material variations inthe quantity of medicines usefully employable in the eye can be achievedby dissolving the medicine from more than one strip into the tears ofthe eye, thus increasing the concentration.

The necessity of keeping bottles of solutions at various strengths is.avoided. Also, the danger of breakage and spillage is lessened.Furthermore, the use of a medicament in liquid form increases the volumeof fiuid in the eye causing the excess liquid to flow out of the eye andthe medicament, already diluted in liquid form; is further diluted inits concentration when it is inserted into the eye fluids. Thisinvention avoids all these problems he cause the medicament in theconcentrated dry form utilizes the eye fluids to form the medicament inconcentrated liquid form. There is thus no increase in the amount offluid in the eye to cause the eye fluids to overflow and there is nodilution of the medicament concentration by the eye fluids themselves.

The accompanying drawing is a diagrammatic representation of a notchedstrip of filter paper one end of which has been varnished and the otherimpregnated with a quantity of medicament.

As many apparently widely different embodiments of the present inventionmay be made without departing from the spirit and scope thereof, it isto be understood that the invention is not limited to the specificembodimerits.

What is claimed is:

1. A medicated ophthalmic applicator comprising an elongated, fiat,thin, absorbent, soft, bibulous filter paper strip having a portionshaped for admission to the eye and impregnated with a dry ophthalmicmedicament miscible with tears.

2. The applicator of claim 1 in which the impregnated portion of thestrip also contains an indicator.

3. The applicator of claim 1 in which the ophthalmic medicament isselected from the group consisting of homatropine HBr, atropine sulfate,pilocarpine HCl, Eserine salicylate, carbamylcholine chloride, and tetracame.

4. The applicator of claim 1 in which the impregnated portion of thestrip carries the ophthalmic medicament in an amount equivalent to about0.125 to 2 mg. of the medicament.

5. A medicated ophthalmic applicator comprising an elongated, flat,thin, absorbent, soft, bibulous filter paper strip having a stifiened,non-absorbent portion convenient for handling, and an absorbent portionshaped for admission to the eye impregnated with a dry ophthalmicmedicament miscible with tears.

6. A medicated ophthalmic applicator comprising an elongated, fiat,thin, absorbent, soft, bibulous filter paper strip having a rounded andnotched portion for admission to the eye impregnated with a dryophthalmic medicament miscible with tears.

7. A medicated ophthalmic applicator comprising an elongated, flat,thin, absorbent, soft, bibulous filter paper strip varnished throughouta substantial port of its length, and a rounded and notched unvarnishedpart for admission to the eye impregnated with a dry medicament misciblewith tears.

References fitted in the file of this patent UNITED. STATES PATENTS1,687,472 Dorman et a1. Oct. 9, 1928 2,702,780 Lerner Feb. 22, 1955 2,703,777 Feinstein et a1. Mar. 8, 1955

1. A MEDICATED OPHTHALMIC APPLICATOR COMPRISING AN ELONGATED, FLAT SOFT,BIBULOUS FILETR PAPER STRIP HAVING A PORTION SHAPED FOR ADMISSION TO THEEYE AND IMPREGNATED WITH DRY OPHTHALMIC MEDICAMENT MISCIBLE WITH TEARS.